Status:
UNKNOWN
Precision Dosing of Busulfan in Children Undergoing HSCT
Lead Sponsor:
University Hospital, Geneva
Conditions:
Hematopoietic Stem Cell Transplantation
Allogeneic Hematopoietic Stem Cell Transplantation
Eligibility:
All Genders
Up to 18 years
Phase:
NA
Brief Summary
The objective of this clinical trial is to evaluate the personalization the conditioning regimen prior to the hematopoietic stem cell transplant (HSCT) in children and adolescents, to improve HSCT eff...
Detailed Description
Participants will be randomly assigned (1:1 ratio, stratified by conditioning regimen - the presence of fludarabine) to receive their first dose of busulfan according to: 1. the most performing metho...
Eligibility Criteria
Inclusion
- Patients must be aged from 0-18 years old on entry to the study;
- Clinical indication of allogeneic or autologous hematopoietic stem cell transplantation;
- The conditioning protocol must include IV Bu formulations, Busulfex® (Otsuka Pharmaceutical), Busilvex® (Pierre Fabre Pharma) or other European Medicines Agency (EMA) or Food and Drugs Administration (FDA) approved generic formulations regardless of the administration schedule (q6h, q12h, or q24h)
- The expected length of time from recruitment to starting the conditioning regimen must be superior to 10 days;
- Informed written consent to participate in the study signed by the participant/parent
Exclusion
- • At least one of the drugs listed below scheduled to be administered in the Bu administration days up to 24h after the last dose of Bu, whenever a washout is not possible:
- Metronidazol (required washout: 7 days)
- Nalidixic acid (required washout: 7 days)
- Phenytoin (required washout: 21 days)
- Itraconazole (required washout: 14 days)
- Ketoconazole (required washout: 7 days)
- Voriconazole (required washout: 7 days)
- Deferasirox (required washout: 7 days)
Key Trial Info
Start Date :
June 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT04822532
Start Date
June 15 2021
End Date
June 1 2025
Last Update
August 2 2021
Active Locations (1)
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1
Hôpitaux Universitaires de Genève
Geneva, Switzerland